Quality at Sanner
For over 130 years, Sanner has manufactured high-volume healthcare packaging and medical products with the consistent quality, reliability, and compliance customers depend on.
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For over 130 years, Sanner has manufactured high-volume healthcare packaging and medical products with the consistent quality, reliability, and compliance customers depend on.
Sanner’s healthcare packaging, compliant with BRC Packaging Materials and ISO 15378, is designed to safeguard sensitive pharmaceutical, diagnostic, and food supplement products from moisture, contamination, and environmental exposure.
Sanner maintains a global Quality Management System (QMS) that spans design, development, and manufacturing, supporting product lifecycle management from concept through commercialization and post-market activities. The QMS applies a risk-based, process-driven approach aligned with ISO 13485:2016 and applicable global regulatory requirements.
Sanner operates under a global QMS aligned with ISO 13485:2016, spanning design, development, and manufacturing. Sanner operations include ISO 13485-certified facilities, ISO 9001 certification, and FDA-, National Medical Products Administration (NMPA) and registered manufacturing locations with demonstrated inspection readiness.
All design centers and manufacturing facilities across the in-house Sanner network, including operations in North America, Europe, and Asia operate within this unified framework under a global Quality Policy while maintaining site-specific ISO certifications and manufacturing establishment registrations aligned to their scope of work. This structure ensures consistent product quality, regulatory compliance, and quality oversight across all regions.
A continuous improvement quality culture across global operations keeps processes sharp, supported by supplier compliance controls and proactive monitoring of evolving regulatory expectations.
When selecting all raw materials, the basic requirement for Sanner is that they comply with the relevant food guidelines (both FDA and EU) (e.g. 1935/2004/EG, 10/2011/EG, 21 CFR 177.1520). For our primary packaging, which is used in the pharmaceutical and medical technology sectors, there is also compliance with the relevant USP and PhEur chapters as well as ISO 10993. Compliance with the regulations is given to our customers in the form of a declaration of conformity or a confirmation of no objection.
